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Rapid and Long-term Clinical Responses Observed in Rheumatoid Arthritis Patients Taking Cimzia® (certolizumab pegol), According to Data Being Highlighted During ACR Meeting
Date:11/5/2010

label) a total of three cases of lymphoma were observed among 2,367 patients.  This is approximately 2-fold higher than expected in the general population.  Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma.  The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤18 years of age), of which certolizumab pegol is a member.  Approximately half of the cases were lymphoma (including Hodgkin's and non-Hodgkin's lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.  Most of the patients were receiving concomitant immunosuppressants.

Cases of acute and chronic leukemia have been reported with TNF-blocker use.  Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Heart FailureCases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.  Certolizumab pegol has not been formally studied in patients with CHF.  Exercise caution when using certolizumab pegol in patients who have heart failure and monitor them carefully.

HypersensitivitySymptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following certolizumab pegol administration.  If such reactions occur, discontinue further administration of certolizumab pegol and institute appropriate therapy.

Hepatitis B ReactivationUse of TNF blockers, including certolizum
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